Manager, Clinical Monitoring

**35Pharma**is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of **Montréal, Canada**, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.

The **Manager, Clinical Monitoring** will be responsible for clinical monitoring activities at clinical sites to ensure compliance with the clinical protocol and study procedures, as well as all applicable regulations, guidelines, quality industry standards, internal standard operating procedures (SOPs) and policies. The Manager, Clinical Monitoring will be responsible to conduct on-site and remote monitoring visits, to review and collect sites essential documents required for the trial master file (TMF), and be the primary point of contact with sites for protocols, recruitment status, and essential documents collection. The Manager, Clinical Monitoring will oversee the CRAs’ performance and workload, ensure training and onboarding, and contribute to the selection of new CRAs.

**Key Responsibilities**:

- Acts as primary point of contact for clinical sites for the conduct of study protocols.
- Supports clinical sites with their patient recruitment initiatives and site-specific recruitment plans.
- Conducts on-site and remote monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, and site close-out visit).
- Prepares or reviews confirmation and follow-up letters to the investigators and monitoring visit reports.
- Prepares and ensures compliance with clinical monitoring plan.
- Participates in the preparation and review of study documents such as clinical protocol, informed consent form, laboratory manual, pharmacy manual, recruitment plan, etc.
- Participates in the planning and conduct of investigator’s meeting.
- Ensures review, collection, and tracking of sites’ essential documents as well as reconciliation with the TMF.
- Conducts co-monitoring visits with contract research organizations (CROs) CRAs or independent CRAs, as necessary.
- Ensures appropriate issue escalation of findings related to the quality of performance of clinical monitoring or site management activities.
- Implements corrective actions and/or training related to clinical monitoring activities.
- Conducts regular CRA group meetings and maintains one-on-one communication with CRAs.
- Interviews, evaluates, and selects new CRAs.
- Conducts orientation of new CRAs and provides continuous training.
- Acts as line manager for CRAs, conducts performance evaluation, and sets-up/reviews objectives.
- Ensures CRAs are meeting performance and quality standards, and takes appropriate remedial actions as required.
- Travels 30% of the time to conduct on-site monitoring visits or to accompany CRAs for co-monitoring visits.
- Supports the clinical sites during regulatory inspections and audits.
- Participates in the development of clinical monitoring SOPs, tools, and templates.
- May contribute to additional clinical operations activities as deemed necessary to ensure the clinical program success.

**Qualifications**:

- Bachelor’s degree in health sciences, nursing degree, or equivalent experience.
- Minimum of 2 years’ experience in a pharmaceutical or biotechnology company or CRO, in a clinical research associate role conducting on-site monitoring visits.
- Minimum of 3 years experience in a Sr CRA, clinical trial management, or project management role in phase 1-3 multicenter clinical trials in a pharmaceutical or biotechnology company, including experience in a CRA line manager role.
- Excellent interpersonal skills, strong written and verbal communication (French and English), and strong presentation skills necessary to meet the needs of various audiences.
- Ability to build effective relationships with site personnel, CRO and vendors staff, and colleagues.
- Superior problem solving, deductive reasoning and decision-making skills.
- Excellent time management and organizational skills, ability to prioritize tasks and accomplish set goals efficiently.
- Excellent attention to detail and ability to maintain detailed and accurate records.
- Excellent interpersonal and communication skills.
- Ability to work independently.
- Excellent knowledge and understanding of the regulatory requirements and good clinical practices.
- Demonstration of the highest ethical standards, active promotion of trust, respect, and integrity.
- Proficiency in required softwares (Word, Excel, Power Point), clinical tri